Senior RA Professional for Development Project within Obesity
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Søborg
Are you able to cut through complexity and drive regulatory strategies for high impact projects and would you like to work together with experts across multiple functions in a global environment? Do you want the opportunity to apply your regulatory experience to an area which embraces the development of both pharmaceuticals and medical devices?
If yes, apply now and join as Senior RA Professional and become part of an exciting environment where engaged people are committed to gain approval of ’s products to bring innovative treatment to patients across the globe. Our people have a unique combination of scientific insight, patient focus, and the ability to navigate many agendas and stakeholders. The position
You will join as Senior RA Professional and have a key role in of one of the teams in RA Obesity. Your main task will be focused on a therapeutic medical device project, entering a comprehensive clinical trial program, pursuing indications for obesity and diabetes treatment. The development of this project is carried out in collaboration with an external partner – thus curiosity and a pragmatic solution-oriented approach will ensure success. In addition, you will take active part in department related activities, including improvement projects across RA.
Your main responsibilities will include: Work closely with the global regulatory lead to develop global regulatory strategies and lead their execution through interactions with cross-functional teams Ensure the implementation of project strategies in clinical trial protocols and applications such as clinical trial applications and investigational device exemptions Prepare briefing packages for interactions with health authorities globally Develop local strategies in collaboration with stakeholders in affiliates to ensure alignment between local and global regulatory strategies Interact with project management, medical and non-clinical specialists, statisticians, and medical writers and collaborate with regulatory colleagues from RA CMC & Device and digital areas, as well as RA in our local affiliates around the globe The position offers ample opportunities for you to continue your individual development in a dynamic, innovative, and collaborative environment, that calls for team spirit, collaborative minds, skilled colleagues, and a great focus on knowledge-sharing. So, look forward to being surrounded by talented, cooperative, and embracing teammates in a strong and empowering culture filled with humble people. Our commitment to innovation also applies to the way we work. We therefore embrace the hybrid workplace – with a blend of home office in Denmark and on-site office-based work in Søborg, Denmark where our team is based. Qualifications
To be a competitive candidate, you should have: A master’s degree or Ph.D. in life sciences, engineering, or another relevant academic field, combined with 5-7 years of regulatory experience within development in the pharmaceutical and/or medical device industry A good understanding of the R&D (research & development) value chain from the medical device and/or pharmaceutical industry Experience in delivering on global regulatory strategies (drug or device), including employment of expedited and accelerated pathways across the major regulatory agencies globally and handling regulatory documentation for pharmaceutical or device development An interest and understanding of management of diabetes and/or obesity would be an advantage Experience in interacting with regulatory authorities on an international scale On a personal level, you demonstrate proactivity and pragmatism whilst being flexible and change oriented, you like to experiment and see opportunities rather than limitations in challenging situations and you are a team player who assists your colleagues and works for joint objectives, shows an inclusive mindset, and respects the diversity in others.
About the department
RA Obesity is a new and expanding area and will soon be 30 dedicated and highly engaged Managers, Global Regulatory leads, specialists, and regulatory professionals, organised into three teams. We are currently managing multiple active projects within Obesity and Diabetes - that span across a wide array of domains and functional areas - and in are responsible for delivering and executing global regulatory strategies. These strategies are designed to advance projects across multiple indications, from the early stages of development through to worldwide submission and approval of initial Marketing Authorisation applications.
We are responsible for driving regulatory strategy, label development, facilitating interactions with health authorities, and overseeing regulatory submissions. These submissions include initial marketing authorisation applications, pediatric plans, and clinical trial applications. We maintain strong ties with our affiliates and global stakeholders, fostering a close collaboration that is integral to our operations. Working at
At , we don’t wait for change. We drive it. We’re a dynamic company in an even more dynamic industry, and we know that what got us to where we are today is not necessarily what will make us successful in the future. We embrace the spirit of experimentation, striving for excellence without fixating on perfection. We never shy away from opportunities to develop, we seize them. From research and development to manufacturing, marketing, and sales – we’re all working to move the needle on patient care.
Contact
For further information, please contact Peter Brun Flarup, Manager RA Obesity 1, +. Deadline
2 June 2024. We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. At we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.
If yes, apply now and join as Senior RA Professional and become part of an exciting environment where engaged people are committed to gain approval of ’s products to bring innovative treatment to patients across the globe. Our people have a unique combination of scientific insight, patient focus, and the ability to navigate many agendas and stakeholders. The position
You will join as Senior RA Professional and have a key role in of one of the teams in RA Obesity. Your main task will be focused on a therapeutic medical device project, entering a comprehensive clinical trial program, pursuing indications for obesity and diabetes treatment. The development of this project is carried out in collaboration with an external partner – thus curiosity and a pragmatic solution-oriented approach will ensure success. In addition, you will take active part in department related activities, including improvement projects across RA.
Your main responsibilities will include:
To be a competitive candidate, you should have:
About the department
RA Obesity is a new and expanding area and will soon be 30 dedicated and highly engaged Managers, Global Regulatory leads, specialists, and regulatory professionals, organised into three teams. We are currently managing multiple active projects within Obesity and Diabetes - that span across a wide array of domains and functional areas - and in are responsible for delivering and executing global regulatory strategies. These strategies are designed to advance projects across multiple indications, from the early stages of development through to worldwide submission and approval of initial Marketing Authorisation applications.
We are responsible for driving regulatory strategy, label development, facilitating interactions with health authorities, and overseeing regulatory submissions. These submissions include initial marketing authorisation applications, pediatric plans, and clinical trial applications. We maintain strong ties with our affiliates and global stakeholders, fostering a close collaboration that is integral to our operations. Working at
At , we don’t wait for change. We drive it. We’re a dynamic company in an even more dynamic industry, and we know that what got us to where we are today is not necessarily what will make us successful in the future. We embrace the spirit of experimentation, striving for excellence without fixating on perfection. We never shy away from opportunities to develop, we seize them. From research and development to manufacturing, marketing, and sales – we’re all working to move the needle on patient care.
Contact
For further information, please contact Peter Brun Flarup, Manager RA Obesity 1, +. Deadline
2 June 2024. We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. At we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.
Information og data
Denne ledige stilling har jobtypen "Apoteker", og befinder sig i kategorien "Sundhed og forskning".
Arbejdsstedet er beliggende i Søborg.
Jobbet er oprettet på vores service den 16.5.2024, men kan have været deaktiveret og genaktiveret igen.
Dagligt opdateret: Dette job opdateres dagligt ud fra jobudbyderens hjemmeside via vores søgemaskineteknologi og er aktivt lige nu.
- 16.05.2024
- Apoteker
- Søborg
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